FDA Inspection 541848 — McKenna Labs Inc
The FDA completed an inspection of McKenna Labs Inc on October 15, 2008 in Fullerton, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 15, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fullerton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4367 | 21 CFR 211.188(b)(13) | Examinations for correct labeling |
| 4371 | 21 CFR 211.188(b)(9) | Description of containers and closures |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |